Abstract
Background
Thermo‐test devices are rarely used outside specialized pain centers because of high acquisition costs. Recently, a new, portable device (‘Q‐Sense') was introduced, which is less expensive but has reduced cooling capacity (20°C). We assessed the reliability/validity of the ‘Q‐Sense' by comparing it with the Thermal Sensory Analyzer (TSA).
Methods
Using a phantom‐skin model, the physical characteristics of both devices were compared. The clinical performance was assessed in a multi‐center study by performing Quantitative Sensory Testing (QST) in 121 healthy volunteers and 83 diabetic patients (Eudra‐Med‐No. CIV‐12‐05‐006501).
Results
Both device types showed ~ 40% slower temperature ramps for heating/cooling than nominal data. Cold/warm detection thresholds (CDT, WDT) and heat pain thresholds (HPT) of healthy subjects did not differ between device types. Cold pain thresholds (CPT) were biased for Q‐Sense by a floor effect (p<0.001). According to intraclass correlation coefficients (ICC), agreement between TSA and Q‐Sense was good/excellent for CDT (ICC= 0.894) and WDT (ICC = 0.898), moderate for HPT (ICC=0.525) and poor for CPT (ICC=0.305). In diabetic patients, the sensitivity of Q‐Sense to detect cold hypoesthesia was reduced in males > 60 years. Moderate correlations between thermal detection thresholds and morphological data from skin biopsies (n=51) were similar for both devices.
Conclusions
Physical characteristics of both thermo‐test devices are similarly limited by the poor temperature conduction of the skin. The Q‐sense is useful for thermal detection thresholds but of limited use for pain thresholds. For full clinical use, the lower cut‐off temperature should be set to ≤18 °C.
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